FDA Advances Clinical Trial Guidelines for Gender Inclusivity

The FDA has issued new guidance documents aimed at enhancing the representation of women in clinical trials. According to the FDA's guidance document titled 'Study of Sex Differences in the Clinical Evaluation of Medical Products,' released in November 2025, the recommendations focus on increasing female enrollment in clinical trials and non-interventional studies.

This is essential for ensuring the generalizability of results and understanding sex-specific responses to medical treatments. Additionally, the FDA's guidance on 'Enhancing Participation in Clinical Trials Eligibility Criteria, Enrollment Practices, and Trial Designs,' issued in December 2025, outlines approaches for sponsors to increase enrollment of a representative population, considering both demographic and non-demographic characteristics.

This includes efforts to include diverse populations in terms of sex, race, ethnicity, and other health factors to assess the impact on safety and effectiveness of medical products. The FDA emphasizes that these guidelines are not binding but aim to promote equitable healthcare by better reflecting the populations likely to use the approved products.